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A NON-RANDOMIZED, MULTI-CENTER, PROSPECTIVE, SINGLE ARM CLINICAL STUDY OF THE
X-SUIT NIR® COVERED BILIARY METALLIC STENT FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE VIA ENDOSCOPIC APPROACH

The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.The objective of…

Immune phenotyping in chronic HCV patients treated with Sofosbuvir and Daclatasvir combination for 12 or 24 weeks * SODA study

Primary objectiveThe primary objective for this study is to analyse the impact of inhibition of viral replication by interferon-free therapy consisting of Sofosbuvir and Daclatasvir (±Ribavirin) on the phenotype and function of the innate immune…

The long-term follow-up interferon-α treatment for chronic hepatitis B infection

To study the long-term effects of interferon-α treatment for chronic hepatitis B patients infection.

Population pharmacokinetics and pharmacodynamics of sorafenib in hepatocellular carcinoma patients with Child Pugh B liver cirrhosis

1. To optimize sorafenib treatment in patients with HCC and CP-B liver cirrhosis by exploration of sorafenib exposure, its variability and predictive factors .Secondary:2. To assess the relation between sorafenib exposure and both toxicity and…

Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of ACUTE hepatitis C genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2)

The goal of this study is to document the efficacy of a shortened 8-week therapy with grazoprevir and elbasvir in patients with acute HCV genotype 1 or 4 infection.

An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients with Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment.

-The primary objective of this study is to investigate the pharmacokinetics (PK) of olaparib after a single oral dose of 300 mg to patients with advanced solid tumours and mild or moderate hepatic impairment compared to those with normal hepatic…

A Phase 2b Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 HCV-Infected Subjects with Renal Insufficiency

(Protocol Am2 dd. 20-Feb-2014, p17/93)The primary objectives of this study are:- To evaluate the safety of sofosbuvir (SOF) 200 mg or 400 mg + ribavirin (RBV) for 24 weeks as assessed by review of the accumulated safety data in each treatment arm-…

Evaluation of the Follow me mode of the AutoLap system- a feasibility study

The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.Study Procedures: No. & type. A total of 35 laparoscopic…

Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex covered stent-graft versus endoscopic treatment for acute bleeding of esophageal varices.

The aim of this study is to compare the new (covered) TIPS stent with the standard treatment, local band ligation and/or sclerosing of the bleeding vessel under endoscopic guidance, in patients with acute bleeding of esophageal varices, with regard…

A randomised, controlled clinical trial assessing the efficacy of;Lanreotide to halt disease progression in ADPKD

First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measured by change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotide modifies…

An Open-Label Study of GS-7977+ Ribavirin with or without Peginterferon Alfa-2a in Subjects with Chronic HCV Infection who Participated in Prior Gilead HCV Studies

The primary objectives of this study are:* To determine the efficacy of GS-7977 + RBV with or without Peginterferon alfa-2a (PEG) as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (…

Acute cholecystitis in high risk patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy; a randomized controlled, open, parallel, superiority, multicenter trial

To demonstrate that primary LC as compared to PC is preferable with respect to morbidity and mortality in high risk surgical patients (APACHE-II score 7-14) with acute calculous cholecystitis.

MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV;Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…

Augmenting response to entecavir using a temporary peginterferon alpha-2a add-on strategy for the treatment of HBeAg-positive chronic hepatitis B (ARES study)
- Long-term follow-up of a peginterferon alpha-2a add-on strategy in chronic hepatitis B patients treated with entecavir

To investigate the use of a temporary peginterferon alpha-2a add-on strategy during entecavir therapy in patients with HBeAg-positive chronic hepatitis B by comparing the efficacy of this regimen versus entecavir monotherapy.To evaluate the long-…

A multi-center, open-label study to assess pharmacokinetics of TKI258 in adult cancer patients with normal and impaired hepatic function

To evaluate the effects of mild, moderate or severe hepatic impairment versus normal hepatic function on the pharmacokinetics of TKI258 in patients with advanced solid tumor

Treatment adherence in patients treated with telaprevir for a chronic hepatitis C genotype 1 infection: an observational study

Primary objective To establish the mean level of adherence to telaprevir in chronic hepatitis C patients during treatment with telaprevir, pegylated-interferon-alfa and ribavirin.Secondary objectives• To establish the mean level of adherence to…

An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects with Advanced Malignancies and Varying Degrees of Hepatic Impairment

The primary objective of this study is to assess the influence of hepatic impairment on area under the curve (both area under the curve, from time 0 to the last concentration measured [AUC0-last] and area under the curve, from time 0 extrapolated to…

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…

A Single dose, two-way crossover study of the bioequivalence of two formulations of Ribavirin

To assess the bioequivalence of two marketed formulations of ribavirin (ribavirin solution and capsules).

Effect of bile drainage and rifampicin, a pregnane X receptor agonist, on clinical and biochemical recovery of patients with obstructive cholestasis

To study the effect of alleviation of obstructive cholestasis by biliary drainage with or without rifampicin on serum bilirubin levels, quality of life, itch intensity, and serum and/or biliary bile salt, ATX, LPA, FGF-19 and biliary HCO3- levels in…